Generic HYDROCORTISONE INN equivalents, drug patent expiration information and freedom to operate

What are the generic sources for hydrocortisone and what is the scope of freedom to operate?

Hydrocortisone is the generic ingredient in seventy-five branded drugs marketed by Allergan Herbert, Crown Labs, Salix Pharms, Bayer Pharms, Monarch Pharms, Valeant Pharm Intl, Westwood Squibb, Pharm Assoc, C And M Pharma, Actavis Mid Atlantic, Alpharma Us Pharms, Altana, Ambix, Everylife, Fougera Pharms Inc, G And W Labs, Ingram Pharm, Ivax Pharms, Lannett Co Inc, Naska, Perrigo New York, Pharmaderm, Pharmafair, Rising, Stiefel, Syosset, Taro, Taro Pharm Inds Ltd, Teligent Pharma Inc, Teva, Topiderm, Usl Pharma, Whiteworth Town Plsn, Valeant Intl, Bausch, Medicis, Paddock Llc, Ani Pharms, Teva Pharms, Healthpoint, Pharmacia And Upjohn, Baker Norton, Solvay, Beta Dermac, Bluline, Heran, Fougera Pharms, Mericon, Dow Pharm, Perrigo Co, Pfizer Global, Cmp Pharma Inc, Dermik Labs, Torch, X Gen Pharms, Mission Pharma, Pfizer, Barr, Breckenridge, Elkins Sinn, Ferrante, Hikma Intl Pharms, Impax Labs, Impax Labs Inc, Inwood Labs, Lannett, Nexgen Pharma Inc, Panray, Parke Davis, Purepac Pharm, Roxane, Sandoz, Vintage, Watson Labs, Merck, Pfipharmecs, Mylan Speciality Lp, Able, Cenci, Ferndale Labs, Sebela Ireland Ltd, Akorn, Bel Mar, Fera Pharms, Colgate, Genus Lifesciences, Glenmark Generics, Taro Pharm Inds, Yamanouchi, Precision Dermat, Lupin Ltd, Abbott, Hospira, Abraxis Pharm, Baxter Hlthcare, Intl Medication, Acp Nimble, Glenmark Pharms Ltd, Perrigo Israel, Sun Pharm Inds Inc, Amring Pharms, Bausch And Lomb, Sandoz Inc, Casper Pharma Llc, Schering, Actavis Labs Fl Inc, Forest Labs, Lederle, and Bioglan, and is included in two hundred and fifty-three NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are sixty-seven drug master file entries for hydrocortisone. Thirty-three suppliers are listed for this compound.

Sponsor	Phase
Tehran University of Medical Sciences	Phase 3
Salah Eldeen Ibrahim Alsherif	N/A
Mohamed Mohi El deen Abo El yazeed	N/A

Sponsor

Phase

Tehran University of Medical Sciences

Phase 3

Salah Eldeen Ibrahim Alsherif

N/A

Mohamed Mohi El deen Abo El yazeed

N/A

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purepac Pharm	HYDROCORTISONE ACETATE	hydrocortisone acetate	CREAM;TOPICAL	086052-001	Approved Prior to Jan 1, 1982		DISCN	No	No	Start Trial	Start Trial				Start Trial
Taro	HYDROCORTISONE BUTYRATE	hydrocortisone butyrate	OINTMENT;TOPICAL	076842-001	Dec 27, 2004	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Sandoz Inc	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE	hydrocortisone; neomycin sulfate; polymyxin b sulfate	SOLUTION/DROPS;OTIC	062423-001	Aug 25, 1983	AT	RX	No	No	Start Trial	Start Trial				Start Trial
Breckenridge	HYDROCORTISONE	hydrocortisone	TABLET;ORAL	207029-003	Apr 27, 2017	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Barr	HYDROCORTISONE	hydrocortisone	TABLET;ORAL	083999-001	Approved Prior to Jan 1, 1982		DISCN	No	No	Start Trial	Start Trial				Start Trial
Teligent Pharma Inc	HYDROCORTISONE	hydrocortisone	LOTION;TOPICAL	203804-001	Jul 27, 2018	AT	RX	No	No	Start Trial	Start Trial				Start Trial
Taro	HYDROCORTISONE	hydrocortisone	OINTMENT;TOPICAL	086257-001	Approved Prior to Jan 1, 1982	AT	RX	No	No	Start Trial	Start Trial				Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Applicant

Tradename

Generic Name

Dosage

NDA

Approval Date

Type

RLD

Patent No.

Patent Expiration

Product

Substance

Delist Req.

Exclusivity Expiration

Purepac Pharm

HYDROCORTISONE ACETATE

hydrocortisone acetate

CREAM;TOPICAL

086052-001

Approved Prior to Jan 1, 1982

DISCN

Start Trial

Taro

HYDROCORTISONE BUTYRATE

hydrocortisone butyrate

OINTMENT;TOPICAL

076842-001

Dec 27, 2004

Start Trial

Sandoz Inc

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

hydrocortisone; neomycin sulfate; polymyxin b sulfate

SOLUTION/DROPS;OTIC

062423-001

Aug 25, 1983

Start Trial

TABLET;ORAL

Apr 27, 2017

Start Trial

TABLET;ORAL

Approved Prior to Jan 1, 1982

DISCN

Start Trial

LOTION;TOPICAL

Jul 27, 2018

Start Trial

OINTMENT;TOPICAL

Approved Prior to Jan 1, 1982

Start Trial

>Applicant

>Tradename

>Generic Name

>Dosage

>NDA

>Approval Date

>TE

>Type

>RLD

>RS

>Patent No.

>Patent Expiration

>Product

>Substance

>Delist Req.

>Exclusivity Expiration

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US Patents:	2
Tradenames:	75
Applicants:	109
NDAs:	253
Drug Master File Entries:	67
Suppliers / Packagers:	33
Bulk Api Vendors:	89
Clinical Trials:	331
Patent Applications:	7,164
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for hydrocortisone
Drug Sales Revenues:	Drug sales revenues for hydrocortisone
DailyMed Link:	hydrocortisone at DailyMed

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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Hydrocortisone - Generic Drug Details

What are the generic sources for hydrocortisone and what is the scope of freedom to operate?

Summary for hydrocortisone

Recent Clinical Trials for hydrocortisone

Pharmacology for hydrocortisone

Medical Subject Heading (MeSH) Categories for hydrocortisone

Synonyms for hydrocortisone

US Patents and Regulatory Information for hydrocortisone

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(11alpha,14beta)-11,17,21-Trihydroxypregn-4-Ene-3,20-Dione
(11beta)-11,17,21-Trihydroxy-pregn-4-ene-3,20-dione
(11beta)-11,17,21-trihydroxypregn-4-ene-3,20-dione
(1S,10S,11S,15S,17S,2R,14R)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyl tetracyclo[8.7.0.0<2,7>.0<11,15>]heptadec-6-en-5-one
(1S,2R,10S,11S,14R,15S,17S)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-5-one
(1S,2R,10S,11S,14R,15S,17S)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0(2),.0(1)(1),(1)]heptadec-6-en-5-one
(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one
(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-3-one
(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3(2H)-one
(8xi,9xi,11beta,14xi)-11,17,21-trihydroxypregn-4-ene-3,20-dione
[3H]cortisol
1050676-88-4
11-beta-Hydrocortisone
11-beta-Hydroxycortisone
11-Hydrocortisone
11,17,21-Trihydroxypregn-4-ene-3,20-dione, (11.beta.)-
11?,17?,21-Trihydroxypregn-4-ene-3,20-dione
11.beta.-Hydrocortisone
11.beta.-Hydroxycortisone
11.beta.,17,21-Trihydroxypregn-4-ene-3,20-dione
11.beta.,17,21-trihydroxyprogesterone
11.beta.,17.alpha.,21-Trihydroxy-4-pregnene-3,20-dione
11.beta.,17.alpha.,21-Trihydroxypregn-4-ene-3,20-dione
11\|A,17\|A,21-Trihydroxypregn-4-ene-3,20-dione; 17-Hydroxycorticosterone; 4-Pregnene-11\|A,17\|A,21-triol-3,20-dione; Cortisol; Kendall inverted exclamation mark s compound F; Reichstein inverted exclamation mark s substance M
11a-Hydroxycorticosterone
11alpha-Hydroxycorticosterone
11b-Hydrocortisone
11b-Hydroxycortisone
11b,17,21-Trihydroxyprogesterone
11beta-cortisol
11beta-Hydrocortisone
11beta-Hydroxycortisone
11beta,17,21-Trihydroxypregn-4-ene-3,20-dione
11beta,17,21-Trihydroxyprogesterone
11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione
11beta,17alpha,21-Trihydroxypregn-4-ene-3,20-dione
1436392-18-5
17-Hydroxycorticosterone
17.alpha.-Hydroxycorticosterone
17a-Hydroxycorticosterone